Androgen and gonadotropin treatment in females

a technology of androgen and gonadotropin, applied in the field of reproductive technology, can solve the problems of reduced egg production, poor quality eggs produced, and female ovarian function decline, so as to improve the oocyte count of females, improve fertility and reproductive outcomes, and increase oocyte production

Inactive Publication Date: 2014-08-21
GLEICHER NORBERT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]The present invention is directed generally to a method of treating a human female using an androgen and a gonadotropin to improve fertility and reproductive outcomes. One embodiment of the method includes administering an androgen in combination with a gonadotropin to a human female. The androgen may be DHEA, testosterone, DHEA sulfate (DHEA-S), androstenedione, any other androgen or a combination thereof. In all embodiments of the invention, the gonadotropin may be follicle stimulating hormone (FSH), luteinizing hormone, human menopausal gonadotropin, any other gonadotropin, or a combination thereof.
[0011]The present invention is further directed to a method of treating a human female to increase oocyte production. One embodiment of the method comprises administering an androgen and a gonadotropin daily or, at least, regularly to the female. The androgen is preferably administered for at least six weeks and the gonadotropin is preferably administered for a period longer than two weeks to improve the female's oocyte count. The periods of androgen administration and gonadotropin administration preferably overlap. The method further includes monitoring the female's follicle count. One embodiment includes stimulating ovulation after the female's follicle count has increased. In another embodiment, the gonadotropin is about 150 IU of follicle stimulating hormone per day. In another embodiment, the androgen is DHEA. In another embodiment, the androgen is testosterone and in other embodiments, other goanadotropins and / or androgens may be used. In all embodiments of the invention, inducing ovulation may include ovarian stimulation by administering a gonadotropin for a period of up to two weeks.
[0012]The present invention is further directed to a method of ovulation induction in a human female comprising administering an androgen to a female for at least six weeks, administering a gonadotropin during those six weeks to stimulate the female's ovaries, inducing ovulation and repeating the gonadotropin administration and ovulation induction less than 120 days after the first ovulation induction while continuing to administer the androgen between the first and second ovulation induction. In one embodiment, the androgen is DHEA. Furthermore, the gonadotropin administration and ovulation induction may be repeated less than 120 days after the second ovulation induction and again less than 120 days after each subsequent ovulation induction while continuing to administer the androgen between each ovulation induction. The androgen may be administered orally.
[0013]The length of time the androgen is administered to the female is at least six weeks. The androgen treatment may preferably continue for more than four months. The length of time the gonadotropin is administered to the female is a period longer than two weeks. The length of time the gonadotropin is administered to the female is preferably more than two months. The androgen treatment and the gonadotropin administration may continue for periods of time longer than four months or indefinitely until a desired condition is achieved.

Problems solved by technology

Females with diminished ovarian function (DOF) have decreased egg production and the eggs that are produced usually are of a poor quality.
Further, females with diminished ovarian function often encounter difficulty becoming pregnant with or without IVF, experience long time periods to conception and / or have an increased possibility of miscarriage and / or an increased possibility of having high number / percentages of aneuploid embryos.

Method used

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  • Androgen and gonadotropin treatment in females
  • Androgen and gonadotropin treatment in females
  • Androgen and gonadotropin treatment in females

Examples

Experimental program
Comparison scheme
Effect test

example 1

Improved Ovulation after DHEA Treatment

[0050]Example 1 shows the effects of androgen treatment in combination with conventional IVF treatment. These effects are significantly increased in the treatment of the present invention, as shown in Example 2.

[0051]In the example study, a 43 year old woman, Patient A, undergoing IVF with banking of multiple cryopreserved embryos for future aneuploidy screen and transfer, is administered an androgen, namely DHEA. In ten months, she undergoes eight treatment stimulation cycles while continuously improving her ovarian response, resulting in oocyte and embryo yields far beyond those previously seen in a woman her age. Patient A's history is unremarkable except for two previous malarial infections. She is allergic to sulfa medications and has a history of environmental allergies. Her surgical history includes umbilical hernia repair at age one and cholecystectomy at age 21. She had used oral contraceptives for over 10 years. She has no history of ...

example 2

Repeated Ovarian Stimulation Cycles in Conjunction with Androgen Treatment

[0063]Overview of Example 2

[0064]Androgens are understood to improve follicle maturation and ovarian reserve. It is reported that at least one function of androgens at early follicle stages is increasing the sensitivity of granulosa cells to follicle stimulating hormone (FSH). A study investigated the results of repeated ovarian stimulation cycles in women undergoing androgen treatment. The study found that repeated ovarian stimulation cycles spaced less than 120 days apart resulted in higher oocyte yields in later cycles than repeated ovarian stimulation cycles spaced 120 days apart or more than 120 days apart.

[0065]Details of Example 2

[0066]Supported by animal and human data, androgens are now recognized as beneficial to follicle maturation. (Gleicher, et al., The role of androgens in follicle maturation and ovulation induction: friend or foe of infertility treatment?, Reproductive Biology and Endocrinology,...

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Abstract

A method of treating a human female with an androgen and a gonadotropin to improve at least one of the human female's infertility, reproductive outcomes and oocyte yield is disclosed. The method may include treating the female with an androgen and a gonadotropin in combination. The androgen may be administered for more than six weeks and the gonadotropin may be administered in a regular low dosage over a period of time longer than two weeks. The method may include inducing ovulation in the female by administering gonadotropins to stimulate ovulation and/or induce ovulation. The method may include multiple additional inductions of ovulation, each within 120 days of the previous induction of ovulation.

Description

[0001]This application is a continuation-in-part of U.S. patent application Ser. No. 13 / 043,266, filed on Mar. 8, 2011, which is a continuation-in-part of application Ser. No. 12 / 123,877, filed on May 20, 2008, now U.S. Pat. No. 8,067,400 B2, and Ser. No. 12 / 575,426, filed on Oct. 7, 2009, now U.S. Pat. No. 8,501,718 B2, and Ser. No. 12 / 610,215, filed on Oct. 30, 2009, now U.S. Pat. No. 8,501,719 B2, which are incorporated by reference herein in their entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to the field of reproductive technology.[0004]2. Description of the Related Art[0005]The related art of assisted reproductive technology revolutionized the treatment of infertility. The most common assisted reproductive technology is in vitro fertilization (IVF), in which a woman's eggs are harvested and fertilized with a man's sperm in a laboratory. Embryos grown from the fertilized eggs are then chosen to be transferred into the fem...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/24A61K31/5685
CPCA61K31/5685A61K38/24A61K31/568A61K2300/00
Inventor GLEICHER, NORBERTBARAD, DAVID H.HARBEN, DWYN V.
Owner GLEICHER NORBERT
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